Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of varicella zoster immune globulin (human) varizig in patients at risk of varicella infection

Conditions: Varicella

Summary: this study is to assess varizig™ for the treatment of patients at risk for developing serious complications from chicken pox.

in most individuals, chicken pox or varicella zoster (vzv) infections are benign; however, in certain at-risk populations such as immunocompromised patients or infants vzv disease can produce significant morbidity and mortality. in such patients, varicella zoster immune globulin (vzig) has been used to prevent or reduce the severity of vzv infections in at-risk patients exposed to individuals with active infections. massachusetts public health biologic laboratories (boston, ma) has discontinued manufacture of the only fda approved vzig product. cangene corporation (winnipeg, canada) is conducting this expanded access ind protocol for varizig™, which is a purified human immune globulin preparation made from plasma of donors with high anti-varicella antibody titers. this study is an open label, non-randomized, expanded access study that will make varizig™ available to eligible patients for whom there is no alternative licensed treatment while a pivotal study is conducted. the study will begin recruiting in february 2006 and will collect safety and basic efficacy data over 42 days following varizig™ administration. physicians will be required to assess measures of varicella infection as well as provide study specific documentation.

Eligibility criteria:
inclusion criteria: * signed informed consent. * cangene corporation varizig™ release requirement. * any of the following at-risk patients exposed to varicella within the previous 96 hours: * immunocompromised pediatric or adult patients. * neonates (less than 1 year of age) and pre-term infants. * pregnant women. * newborns whose mothers had vzv infection shortly before delivery (\< 5 days) or after (\< 2 days) delivery. * healthy non-immune adults exclusion criteria: * hypersensitivity to blood or blood products, including intravenous (iv) or intramuscular (im) human immunoglobulin preparations. * selective immunoglobulin a (iga) deficiency. * evidence of vzv infection. * evidence of zoster infection. * known immunity to vzv(previous varicella infection or varicella vaccination) * severely thrombocytopenic ( platelets \< 50 x 10x9 / l )

Keywords: immune compromised varicella zoster virus ( vzv) infection pediatric
effect of grape seed extract plus ascorbic acid on endothelial function

Conditions: Coronary Artery Disease

Summary: a pilot study of 15 subjects will be conducted to confirm an acute effect of grape seed extract on endothelial function. we then will perform a a randomized, double blind, placebo controlled crossover study designed to investigate the benefit of grape seed extract/vitamin c treatment on endothelial function. participants (n=40) will take a food supplement containing 450 mg of grape seed extract and 1500 mg of vitamin c or matching placebo for four weeks and then cross over to the alternative treatment (active supplement or placebo) for four weeks. we will examine endothelial function before and after each of the two treatment periods. the study will provide information about the vascular effects of these compounds.


Eligibility criteria:
inclusion criteria: * coronary artery disease exclusion criteria: * pregnancy * clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate. * treatment with an investigational new drug within the last 30 days. * history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. * vitamin e, vitamin c, and beta carotene, lipoic acid, and other food or herbal supplements within 1 month of enrollment.

Keywords: endothelium antioxidants flavonoids
comparison of transbronchial cryobiopsy and forceps biopsy in lung transplant recipients

Conditions: Lung Transplant Rejection; Lung Transplant Failure and Rejection

Summary: clad is defined as loss of lung function after other factors, particularly infections have been excluded. readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.

eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. the current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. the value of cryobiopsy to obtain a conclusive diagnosis of acr is discussed controversially due the lack of safety and efficacy data in lung transplant recipients

Eligibility criteria:
inclusion criteria: * routinely performed surveillance bronchoscopy and when indicated including serial fb and cb in the same session in patients wo had undergone lung transplant * male or female subject of at least 18 years of age * written informed consent after participant's information signed by patient exclusion criteria: * age \< 18 years * lacking ability to form an informed consent (including impaired judgement, communication barriers) * contraindication against bronchoscopy (e.g. co-morbidities) * inr \> 2 or thrombocytes \< 50000 * double antiplatelet drugs (e.g. ass and clopidogrel) within 7 days before biopsy * anticoagulation with noak within 48 hours before biopsy * moderate or severe pulmonary hypertension (mpap \> 30 mmhg, rv/ra \>30 mmhg)

Keywords: cryobiopsy transbronchial biopsy
clinical trials to compare the effects of pioglitazone and evogliptin on hepatic fibrosis in patients with chronic hepatitis b with significant hepatic fibrosis with type 2 diabetes

Conditions: Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

Summary: the clinical study determines the effect of evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis b to confirm the improvement of hepatic fibrosis.


Eligibility criteria:
inclusion criteria: * adultes between 20 and 80 years of age * patients who satisfy the following conditions among chronic hepatitis b patients diagnosed with type 2 diabetes 1. patients who are newly diagnosed as type 2 diabetes : 6.5% ≤ hba1c \< 10.0% 2. patients who are already diagnosed as type 2 diabetes: hba1c \< 10.0% * patients who have significant liver fibrosis of at least 7 kpa in a hepaticity test using fibroscan * patients who voluntarily signed the consent form after informed on the object, method, benefits and risks of the clinical study exclusion criteria: * patients who were taking pioglitazone or evoglipitin medication or who took diabetes medication within 4 weeks at the time * patients who meet the standard of alcoholic fatty liver (in excess of 210g per week for men and 140g per week for women over the last two years) * liver cirrhosis patients with impaired liver function (ctp class b and c) * patients who took drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.) * patients with acute or chronic metabolic acidosis with or without coma and history of ketonic acid (within 24 weeks) * allergic or hypersensitive to the target drug or its composition; * patients treated with oral or non - oral corticosteroid treatment for chronic (more than 14 consecutive days) within 8 weeks prior to screening. * poor nutrition, starvation, and debilitating conditions (including severe infections and severe injury patients before and after surgery) * patients who are receiving radiation and chemotherapy for malignant tumors or patients who have been on chemotherapy or radiation treatment for less than two years. * patients with heart failure in 24 weeks (class iii to iv in nyha classification) or unregulated arrhythmia. * patients with acute cardiovascular disease in 12 weeks or less (e.g. unstable angina, myocardial infarction, routine ischemic seizures, cerebrovascular disease, coronary bypass surgery, or coronary artery interventions). * patients with renal failure, chronic neuropathy (estimated glomerular filtration rate \<60 ml/min/1.73 m2) or dialysis * anemia patients whose hb levels are less than 10.5g/dl * women who are pregnant or breastfeeding * patients who do not agree to use proper contraception during clinical trials only for women or men. * patients who took medicines for clinical trials in other clinical trials within four weeks of document consent * patients who are unable to participate in clinical trials on the judgment of other researchers * patients who cannot read the consent form (e.g. illiteracy, foreigners, etc.)
mvct imaging pilot study using helical tomotherapy

Conditions: Cancer, Carcinoma

Summary: to compare the two types of scans, the conventional ct planning scan and the tomotherapy planing scan.


Eligibility criteria:
inclusion criteria: * undergoing radiotherapy metallic artifact in radiation field. exclusion criteria: * contraindication to radiotherapy

Keywords: helical tomotherapy megavoltage imaging
the effect of fluvastatin xl® treatment in patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this study evaluated safety, tolerability and efficacy of fluvastatin xl® -extended release (80 mg once daily) in patients with metabolic syndrome


Eligibility criteria:
inclusion criteria: * ≥ 3 criteria for metabolic syndrome national cholesterol education program adult treatment panel iii (ncep atp iii criteria) * triglyceride (tg) \< 400 mg/dl and low density lipoprotein-cholesterol (ldl-c) 100 mg/dl to 190 mg/dl * written informed consent for participating in the study exclusion criteria: * severe renal disease or renal dysfunction * chronic liver disease or liver function impairment * inflammatory muscle dysfunction or findings of muscle problems * severe cardiac failure other protocol defined inclusion exclusion criteria may apply

Keywords: metabolic syndrome,dyslipidemia,fluvastatin extended release
evaluation of a new multiplex quantitative pcr technique for the diagnosis of echinococcosis

Conditions: Echinococcosis; Diagnosis

Summary: echinococcosis is a severe parasitosis caused by the development of the tapeworm larva echinococcus multilocularis, responsible for alveolar echinococcosis (ae) or echinococcus granulosus, responsible for cystic echinococcosis (ce). the treatment is based on surgery (only possible in 30 to 40% of cases) and/or on a benzimidazole antiparasitic treatment, especially albendazole. albendazole is only parasitostatic, it slows down the development of the parasite but does not kill it. it is often prescribed for life. monitoring the effectiveness of the treatment is therefore necessary, requiring radiological and serological monitoring once or twice a year. being a chronic disease whose treatment is not always curative, patients quality of life is impacted, with a high level of anxiety described in some patients. the diagnosis, evoked on radiological arguments, is then confirmed by serological techniques, whose sensitivity for ea diagnosis is good (95%) in the absence of immunosuppression (now observed in 25% of ea patients). sensitivity is lower for ce diagnosis (70% or even less than 50% in certain clinical forms). quantitative real-time pcr (qpcr) techniques on blood samples are now used in many infectious pathologies to quantify the circulating dna load, and improve diagnosis and therapeutic monitoring. the presence of circulating parasitic dna has been reported in both types of echinococcosis. a new echinococcus spp.multiplex qpcr technique (qpcr-echino) allowing the detection of dna from e. multilocularis and different species of the e. granulosus complex of european occurrence, in different types of biological samples, has recently been developed in the french national reference center for echinococcosis laboratory. the investigators wish to evaluate qpcr-echino for the detection of dna in tissues, as well as in blood, for the diagnosis of echinococcosis. this technique could improve the sensitivity of biological diagnosis, especially in immunocompromised patients, who often experience significant diagnostic delays, and could also provide information on the virulence and viability of the strains involved.


Eligibility criteria:
inclusion criteria: * men and women aged \>18 years with a diagnosis of echinococcosis (alveolar echinococcosis or cystic echinococcosis) established according to the reference criteria * signature of the informed consent form indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions about this study * affiliation to a french social security scheme or beneficiary of such a scheme. exclusion criteria: * legal incapacity or limited legal capacity * subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator * subject without health insurance * pregnant woman * subject being in the period of exclusion from another study or provided by the "national volunteer file".

Keywords: high sensitive qpcr
study of pant type absorbing urinary incontinence products

Conditions: Urinary Incontinence

Summary: pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population

the clinical clinical investigation is prospective, cross-over, interventional, multicentre and pre-market. the investigation aims to demonstrate the performance and safety of a new absorbing hygiene product (medical device) when used as intended in subjects affected with light to medium urinary incontinence compared to a reference (control) product representing standard of care. the study participants will be randomly assigned to one of 4 groups. each group will receive a predefined pair of investigational and reference products (variants: either high waist or low waist) to be used in a predefined order (crossover design: investigational or reference product to be used first). hence, each study subject will use two products (one investigational product and a corresponding reference product of the same variant) and act as its own control. the study subjects will use one product for 5 days and then switch to use the other product for 5 days. the primary endpoint for the investigation is the comparison in leakage performance of the investigation product with the reference product. there are also secondary endpoints regarding safety and product satisfaction and product preference.

Eligibility criteria:
inclusion criteria: * adult women between age 45 and 75. * be willing and able to provide informed consent. * capability and willingness to follow the protocol. * experience incontinence daily or at least two times a week. * uses some sort of protection for the incontinence daily or at least two times a week. * uses five or more pieces of protection per week. * is currently using protective underwear; a pull-up (pant) product made for incontinence. * is able to wear a pant product of size m. * is currently using tena silhouette or always discreet boutique product. * should be affiliate to the social security system. exclusion criteria: * is pregnant or nursing. * known allergies or intolerances to one or several components of the investigational products. * be dependent on either alcohol or recreational drugs. * participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation. * being under safeguard and protection of justice * having cognitive impairments. * any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
low-level laser therapy for the treatment of diabetic foot ulcer

Conditions: Diabetic Foot Ulcer

Summary: the study evaluates the efficacy of low-level laser therapy on ulcer healing in patients with diabetic foot ulcer. half the patients are randomized to receive low-level laser therapy and a half to recieve the placebo (led).

low-level laser therapy(lllt) has been reported to aid ulcer healing in patients with diabetic foot ulcer. however, patients need to come to hospital to receive lllt performed by medical professional. the lllt shoe has been developed for home using. patients can wear lllt shoe 30 min once daily instead of going hospital for llt therapy. the aim of this study is to see whether lllt shoe helps with healing compare with placebo (led shoe).

Eligibility criteria:
inclusion criteria: * patients with chronic diabetic foot ulcer * ankle brachial index ≥ 0.4 * toe pressure brachial index ≥ 0.3 * transcutaneous oxygen measurement (tcom) ≥ 40 mmhg * ulcer size less than 25 cm2 exclusion criteria: * infected ulcer * fever * hba1c \> 15 %

Keywords: diabetic foot ulcer low level laser therapy
can pre-operative anemia be timely identified and optimized in patients awaiting primary arthroplasty surgery? a randomized clinical trial

Conditions: Anemia; Hip Osteoarthritis

Summary: reducing the occurrence of anemia (low circulating hemoglobin levels) post-surgery has been associated with improved outcome, as it reduces complications and allows for faster return to pre-operative function. post-operative hemoglobin level is dependent upon its pre-operative value (for a given amount of blood loss). about 17% of patients at the ottawa hospital (toh), will be anemic pre-operatively, and if left untreated the patients will have significantly inferior outcomes compared to non-anemic patients. in order to improve outcomes, when a patient is identified as anemic, typically at the pre-operative assessment clinic, he/she is invited to be reviewed and optimized at the pre-operative blood optimization clinic (pboc). however, only a quarter of anemic patients are seen in the pboc due to the lack of time available between anemia identification and surgery and the current resources available. this project will focus on hemoglobin level optimization of pre-operative hip and knee, primary, arthroplasty patients to demonstrate whether early assessment and treatment of pre-operative anemia can be successfully integrated into practice and its impact on post-operative outcomes. patients will be randomly assigned to either the current standard of care pathway with an anemia test at the pre-operative assessment clinic (2-4 weeks before surgery), at which time they have the option to seek treatment. patients who are randomly selected to be in the experimental group, will undergo a test to detect anemia at the time they consent for surgery, which is usually 4-6 months prior to surgery. patients with anemia, will be invited for treatment at the blood optimization clinic at this time. in doing so, this project will test whether timely identification and simple measures is feasible and whether such practice can reduce the overall anemia burden and ultimately improve patient outcome.


Eligibility criteria:
inclusion criteria: * 18 years of age * undergoing primary arthroplasty procedure * willing and able to provide informed consent exclusion criteria: * patients who are not eligible for assessment and optimization in the preoperative blood optimization clinic. this includes patients with end-stage renal disease (esrd) or other renal conditions under the care of nephrologists, receiving erythropoietin treatment * patients with known hematological malignancy or other hematological conditions which are already on some form of anemia treatment
assessment of right ventricular function by cardiac mri in patients with pulmonary arterial hypertension (irma)

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary hypertension (ph) is a pathophysiological condition defined by an increase in pulmonary arterial pressure above 20mmhg, which encompasses many very dissimilar conditions. right ventricular function is the major determinant of survival in these patients. currently, right ventricular function is estimated by trans-thoracic echocardiography via the measurement of standardised parameters. however, cardiac magnetic resonance imaging is now the reference technique for non-invasive quantification of volumes, mass, function of the right ventricle but can also be useful for the consideration of the pulmonary circulation. thus, indices of function can be extracted and it plays an increasing role in the prognostic evaluation of the right heart function at diagnosis and at re-evaluation under treatment of pulmonary arterial hypertension. this work will initially focus on the assessment of right ventricular myocardial work by echocardiography and cardiac magnetic resonance imaging in comparison with invasive haemodynamic data.


Eligibility criteria:
inclusion criteria: * patient with pulmonary arterial hypertension (group 1) * patient with cardiac mri, echocardiography and right heart catheterisation within 1 month of each other exclusion criteria: * patient with features of venous/capillary involvement * pulmonary arterial hypertension associated with with congenital heart disease * patient's decline to participate in the study
non-invasive optical angiography in age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: age-related macular degeneration (amd) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout europe and the us. among these patients, about 6%-8% are afflicted with the advanced stages of amd, which are responsible for the most severe visual loss. there is now convincing evidence that vascular endothelial growth factor (vegf) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of amd. today, the gold standard for vascular imaging of the retina and diagnosis of cnv is angiography using fluorescein (fla) or indocyanine green (icg), which involves injection of the dye into a vein of the arm. in the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. these developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. the proposed study tests the hypothesis that visualisation of cnv lesion size with non-invasive oct angiography is not inferior to fla/icg angiography in treatment naïve and previously treated amd patients.


Eligibility criteria:
inclusion criteria: - patients with active cnv due to amd as assessed by fla/icg angiography within 1 week prior to study inclusion exclusion criteria any of the following will exclude a patient from the study: * previous application of intravitreal drugs except anti-vegf injections * active intraocular inflammation * presence of an intraocular disease except amd and cataract

Keywords: oct angiography